Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
This fsca was initiated in order to replace the forceps elevator mechanism and the o-rings consistent with the design of the upgraded duodenoscope model ed34-i10t.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Pentax medical has become aware that the video editing tool included in the 9310hd video capture module, corel video studio version x9, may not be compatible with the exam video format. this video editing tool is provided for the purpose of editing exported exams for inclusion in presentations and for other collaborative purposes.
Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Singapore.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Permobil states that the seats of the above wheelchairs may come loose when mounted in a high position because of a weld failure in the seat plate and the lack of a seat support, potentially leading to user falls.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The primary packaging, constituted of blister has in some cases a crack leading to a risk of loss of sterility of the device.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The manufacturer received a complaint that the silicone catheter showed an irregular surface after it had been subjected to a high tensile load. thereupon the manufacturer carried out some tests on the affected catheters which confirmed this observation.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCAR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Soft tip became detached from frazier micro suction cannula.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Pfm medical has identified potential risk of detachment of small particles from the soft tip of the nit-occlud implantation sheath as a result of mechanical stress .
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR, MHRA
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
When the heartstart mrx with q-cpr meter is used. if the user continues to deliver chest compressions when the shock advisory analysis begins or when the device is charging to the selected energy, the ‘do not touch the patient’ icon incorrectly remains on the screen.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Philips/ respironics everflo oxygen concentrator 1102443 has the electrical rating of 230v 60hz.
however, one of the components inside the device, a compressor has a label indicating 230v 50hz,
please see below figure 1. the same component also has additional label on the back side, see figure 2,
this second label has the correct electrical frequencies 50/60 hz. therefore, our intent is to clarify
presence of the two labels and assure of safe device performance.
we would like to inform our customers that the philips everflo oxygen concentrator is fully compliant
to iec 60601 and sfda.Md/iec 60601-1-1, as per sfda’s national provision article six. the
shipping box (package) label and device label are provided in attachment.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Philips has identified the possibility that, on rare occasion, the philips efficia dfm100 defibrillator/ monitor (p/n 866199) –, when powered-on in aed mode, may stop operating and reboot.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The defect involves the clock signal component within the firewall. this component has a high probability of failing in appliances that have been running for greater than 18 months. if the clock signal component were to fail, the firewall will stop functioning, will not boot, and is unable to recover from the component failure.
this failure will result in a loss of communication between devices that are separated by the firewall, which may cause the information center to reboot.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Investigation of a remark / feedback from the field showed that the displayed air kerma (ak) is using an incorrect point of reference. this is a defect per 21 cfr 1003, system design. the system must be calibrated according to ak and akr per 21 cfr 1020.32(d). air kerma is to express the radiation delivered to a point, such as the entrance surface of a patient’s body.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Philips healthcare has identified that it is possible for the suresigns vs2+ patient monitor to lock up and stop monitoring during patient use.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The listed trilogy devices support dual therapy prescriptions, and two prescriptions may be programmed by a healthcare professional specific to the patient’s needs as prescribed by physician. philips respironics has become aware that trilogy ventilators with software versions 13.2.04, 13.2.05, 14.0.00 or
14.1.01 are susceptible to an inadvertent change between prescriptions. this may occur under a particular set of operating conditions and after a specific sequence of key presses without requiring confirmation of the change by the user.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
The first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. if the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
If by an electrical connection failure between motor speed sensor and digital motion control board or a related software defect, the movement speed regulation does not work as intended, the device may move with increasing speed and/or into a wrong direction after releasing the dead man switch (handle bar) during 1,5 seconds maximum till the brake is activated.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Causa
Erroneous velocities may be reported when using high pulse repetition frequency (hprf).
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Notas adicionales en la data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company
Causa
Philips has recently become aware of collisions and excessive force exerted on the lower portion of the detector arms of precedence and skylight spect systems which may have resulted in the detector arms breaking. a collision or excessive force may lead to a crack or fracture in the upper portion of the arm, which may cause the detector arms to break and the arm and detector to fall.